GSK will provide fill and finish manufacturing capacity at the facility in the North East of England. Promising a rapid technology transfer between the two companies, beginning immediately, GSK hopes to be in a position to start manufacture of NXV-CoV2373 at the beginning of May.
Meanwhile, the protein antigen component of the vaccine is also being produced in the same region by Novavax' manufacturing partner, Fujifilm Diosynth Biotechnologies, at its site in Billingham, Stockton-on-Tees.
Roger Connor, President, GSK vaccines, said: "GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally."
Rick Crowley, Executive Vice President and Chief Operations Officer, Novavax, added: "This partnership with GSK continues the expansion of our global supply network, which we expect to increase overall production capacity and, if approved by regulatory agencies, support access to a potentially important new vaccine against COVID-19."
Novavax’s protein-based COVID-19 vaccine showed 89.3% efficacy in a UK Phase 3 clinical trial, including protection against the UK B.1.1.7 variant.
While it has not yet received any authorizations for use, Novavax has already started a rolling review with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and plans to submit a full application in Q2. (Elsewhere, it has also started rolling reviews with the EU’s EMA, the US FDA and Health Canada).
GSK, the UK Government Vaccines Taskforce and Novavax have reached an agreement in principle; and GSK and Novavax are now working on a final agreement.
The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax.